Description of Event or Problem · 1
THE PINTLER HEATING PAD ON THE OPERATING ROOM TABLE WAS NOTED TO BE HOT ON ONE SIDE AND NO HEATING WAS OBSERVED ON THE CENTER OR OTHER SIDE. THE CONTROL UNIT WAS ON AND DID NOT INDICATE ANY AUDIBLE OR VISUAL WARNING CONDITION OR ALARM. THIS WAS NOTED BETWEEN OR CASES. THE PAD WAS REMOVED FROM SERVICE. MANUFACTURER RESPONSE FOR HEATED PAD FOR OR TABLE, PEAK OR WARMING PAD (PER SITE REPORTER). TESTING BY HOSPITAL CLINICAL ENGINEER SHOWED THAT THE SURFACE TEMPERATURE EXCEEDED 100 DEGREES C ON THE ONE SIDE WITHOUT THE UNIT SHUTTING OFF OR ALARMING. THE MANUFACTURER REP CUT CAME TO INVESTIGATE AND CUT OPEN THE PAD. SIGNIFICANT CHARRING WAS FOUND ON THE ENTIRE LENGTH OF THE COPPER BUS ON THE SIDE OF THE PAD THAT WAS HOT. THIS BUS WAS SECURELY CRIMPED TO THE BLACK WIRE FROM THE CONTROL UNIT. NO CHARRING WAS EVIDENT ALONG THE ELECTRICAL BUS ON THE OPPOSITE SIDE OF THE PAD, BUT THAT BUS WAS NOTED TO BE DISLODGED FROM THE CRIMP CONNECTION TO THE RED WIRE FROM THE CONTROL UNIT. THE MANUFACTURER REP NOTED THAT THE FAILED CRIMP CONNECTION WAS LIKELY TO BE RESPONSIBLE FOR THE EVENT. TESTING IS DONE BY THE MANUFACTURER AFTER FINAL ASSEMBLY TO ASSURE THAT THE RESISTANCE BETWEEN THE TWO ELECTRICAL BUSES IS WITHIN SPECIFICATION. THE MANUFACTURER REP INDICATED THAT NO TESTING IS DONE TO ASSURE GOOD MECHANICAL CONNECTIONS OF THE CRIMP CONNECTIONS. ALSO, TESTING OF OUTPUT SURFACE TEMPERATURES IS NOT DONE AFTER FINAL ASSEMBLY.